Knee OsteoarthritisPhase 2NCT05796765
Phase 2B Micronized DHACM vs. Saline in the Treatment of Knee Osteoarthritis
A Phase 2 study testing Micronized DHACM 40 mg, Micronized DHACM 100 mg and Saline in people with Knee Osteoarthritis, run by MiMedx Group, Inc. at 14 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of the 40 mg and 100 mg doses of allogeneic micronized dehydrated human amnion/chorion membrane (micronized DHACM) injectable compared to 0.9% sodium chloride injection, placebo control for the treatment of knee osteoarthritis Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Micronized DHACM 40 mg, Micronized DHACM 100 mg and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 14 sitesUnited States
- Study dates
- 24 Mar 2023to 15 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is age ≥ 21 and ≤ 80 years.
- Subject has a diagnosis of primary OA of the target knee (as per American College of Rheumatology clinical and radiological criteria) with OA symptoms (as reported by the subject) that have been present for at least 6 months prior to Screening.
- Subject has Grade 2 or 3 OA of the target knee on the Kellgren Lawrence (KL) grading scale as evaluated by central reading of screening X-ray.
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
- Subject must have a WOMAC pain score ≥ 4 and ≤ 9 out of 10 in target knee, at screening and baseline.
- Subject must have tried and failed to adequately respond to 2 knee OA standard of care (SOC) therapies, including at least one pharmacological treatment, for a minimum of 3 months. SOC for knee OA include non-pharmacological (exercise, weight loss, knee braces, cane) and pharmacological treatments (topical nonsteroidal anti-inflammatory drugs [NSAIDs], oral NSAIDs, and intra-articular corticosteroids).
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- Subject must be willing to discontinue all current pain medications (including but not limited to oral, topical, intra-articular) during the duration of the study except for acetaminophen (paracetamol) which will be allowed as rescue, except as noted in inclusion criterion 10 below. Limited use of NSAIDS will be permitted at the discretion of the investigator for post injection pain only.
- Subject must have a WOMAC pain subscale score in contralateral knee less than 4 out of 10, at screening and baseline visits.
- Subject who is identified as having taking analgesics at their initial screening visit 1a must be willing to abstain from analgesics for a washout period of 5 half-lives of the analgesic plus 48 hours and return for screening visit 1b where WOMAC pain can be collected analgesic-free.
- Subject must be willing to abstain from use of rescue medication (acetaminophen/paracetamol) for at least 72 hours prior to all study visits subsequent to screening.
- For male subjects:
- Subject must agree to use highly effective contraception throughout the study.
- Subject must agree not to donate sperm during the study.
- For female subjects:
- Subject is surgically sterile; or
- Has been amenorrheic for at least 1 year and is over the age of 55 years; or
- Has a negative urine pregnancy test and agrees to use acceptable contraceptive measures (e.g. hormonal contraceptives, barriers with spermicide, intrauterine device or vasectomized partner) from the time of informed consent through the end of the study; and
- Must commit to the use of highly effective form of birth control from the time of informed consent through the end of the study.
- Subject must have vital signs within the following ranges at the screening visit and at the baseline visit before investigational product administration:
- Systolic blood pressure ≤140 and ≥90 mmHg,
- Diastolic blood pressure ≤90 and ≥60 mmHg,
- Heart rate <100 and >60 bpm,
- Temperature: normal,
- Respiratory rate <20 and >12 /min.
Who cannot join
- Subject has Grade 1 or 4 OA of the target knee on the Kellgren Lawrence (KL) grading scale as evaluated by central reading of screening X-ray.
- Subject has a BMI greater than 40 kg/m^2.
- Subject has a clinical effusion (3+) of the target knee according to the Stroke Test grading system.
- Subject has symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an intra-articular loose body.
- Subject has any active infection of the target knee, and/or any active systemic or local infection.
- Subject has a history of allergy or sensitivity to any of the investigational product components, including aminoglycoside antibiotics.
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- Symptomatic pain in either or both hips that exceeds that of the target knee, as determined by investigator assessment.
- Significant radicular back pain, as determined by investigator assessment.
- Subject has rheumatoid arthritis, psoriatic arthritis, or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer.
- Subject has documented history of gout or pseudogout.
- Subject has fibromyalgia or any other chronic pain disorder.
- Subject has an autoimmune disease or a known history of having acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV).
- Subject has received any of the following to the target knee:
- Intra-articular hyaluronic acid (HA) injection within 24 weeks prior to screening;
- Intra-articular short-acting corticosteroid such as triamcinolone within 12 weeks prior; if long-acting (Zilretta) within 5 months prior to screening;
- Platelet rich plasma (PRP) injection within 6 months prior to screening;
- Is planning to receive physical therapy during the study;
- Has had or is planning to have major surgery or arthroscopy in the target knee within 52 weeks of treatment;
- History of a total knee arthroplasty.
- Subject has a history of total knee arthroplasty in the contralateral knee within the last 12 months.
- Subject has received any prior treatment with tissue engineered or amniotic products, including any MIMEDX product.
- Subject has used an investigational drug, device, or biologic within 12 weeks or 5 half-lives of the investigational product prior to screening.
- Subject has been exposed to investigational use of nerve growth factor (NGF) antagonists.
- Subject uses any opioids to control their pain.
- Subject is taking a drug with known or suspected immunosuppressive effects.
- Subject with a history of systemic corticosteroid use within three months of screening and subjects who are likely to need systemic steroids during the study (e.g., poorly controlled asthma, severe COPD).
- Subject is breast feeding.
- Subject has had prior radiation therapy to the target or contralateral knee.
- Subject is currently taking anticoagulant therapy (excluding Plavix or similar or low dose aspirin).
- Subject has a known or suspected history of alcohol, narcotic or other drug abuse or substance dependence within the past 12 months, prior to screening.
- Subject has any significant medical or psychiatric condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
- Subject has any of the following uncontrolled co-morbid conditions: cirrhosis, Child Class B or C liver disease, or other clinically significant indicators of liver disease, such as portal hypertension; eGFR <60 mL/min/1.73 m^2 by the CKD-Epi formula; hemoglobin A1c >8.0 mmol/mol; hemoglobin <11.0 g/dL; coagulopathy; systolic blood pressure (BP) >140 or <90 mmHg, diastolic BP >90 or <60 mmHg, or heart rate (HR) ≥100 or ≤60 bpm.
- Subject has a history of malignancy of any organ system (localized squamous or basal cell carcinoma of the skin are not exclusionary unless localized at the injection site), treated or untreated within 2 years of screening.
- Subject has a worker's compensation or disability claim related to their knee osteoarthritis.
- Subject requires more than intermittent use of a rollator, walker, cane, or other assistive devices.
- Subject currently using marijuana in any form, including but not limited to topical or oral methods of use.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University Orthopedics Center - Altoona
Altoona, Pennsylvania, 16602
Elite Clinical Trials, LLLP
Blackfoot, Idaho, 83221
ClinRX Research Joseph, Inc.
Carrollton, Texas, 75007
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020
Piedmont Research Partners, LLC
Fort Mill, South Carolina, 29707
Healthcare Research Network
Hazelwood, Missouri, 63042
Horizon Clinical Research
La Mesa, California, 91942
AppleMed Research Group, LLC
Miami, Florida, 33126
Health and Life Research Institute, LLC
Miami, Florida, 33155
Vista Health Research, LLC
Miami, Florida, 33176
Rochester Clinical Research, Inc.
Rochester, New York, 14609
University Orthopedics Center - State College
State College, Pennsylvania, 16801
Premier Medical Associates
The Villages, Florida, 32159
About this study
Official title: A Phase 2B, Prospective, Double-Blind, Randomized Controlled Trial of the Micronized DHACM Injectable Product Compared to Saline Placebo Injection for the Treatment of Osteoarthritis of the Knee
The purpose of this study is to determine the safety and efficacy of the 40 mg and 100 mg doses of allogeneic micronized dehydrated human amnion/chorion membrane (micronized DHACM) injectable compared to 0.9% sodium chloride injection, placebo control for the treatment of knee osteoarthritis
Read the detailed description
This is a phase 2B, prospective, double-blind, randomized controlled trial of the micronized DHACM injection as compared to saline placebo injection in the treatment of osteoarthritis of the knee. Approximately 30 experienced clinical centers in the United States and Denmark will participate in the study. Each subject will receive one injection and be evaluated for efficacy and safety during the 12-month observation period. Endpoints will be measured at 30 days, 60 days, 90 days, 120 days, 150 days, 180 days, 270 days and 365 days.
- Conditions
- Knee Osteoarthritis
- Being tested
- Micronized DHACM 40 mg, Micronized DHACM 100 mg, Saline
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized DHACM 40 mgBiological
Injection of 40 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP
Micronized DHACM 100 mgBiological
Injection of 100 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP
SalineDrug
Injection of 2.5 ml, 0.9% Sodium Chloride, USP
| Study group | Role | What they receive |
|---|---|---|
| Micronized DHACM 40 mg | Experimental | Injection of 40 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP Receives: Biological: Micronized DHACM 40 mg |
| Micronized DHACM 100 mg | Experimental | Injection of 100 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP Receives: Biological: Micronized DHACM 100 mg |
| Saline | Placebo comparator | Injection of 2.5 ml, 0.9% Sodium Chloride, USP Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC pain subscale score between baseline and Day 180
Efficacy Endpoint
Measured: 180 days
Change in WOMAC function subscale score between baseline and Day 180
Efficacy Endpoint
Measured: 180 days
Proportions of subjects who report treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Safety Endpoint
Measured: 365 days
Secondary outcomes (5)
Proportion of subjects who report greater than the minimal clinically important difference (MCID) improvement in WOMAC pain and function compared to baseline at Day 90 or Day 180
Secondary Efficacy Endpoint
Measured: 90 Days, 180 Days
Change in SF-36 physical component score (PCS), mental component score (MCS), and domain scores between baseline and Day 90 or Day 180
Secondary Efficacy Endpoint
Measured: 90 Days, 180 Days
Change in patient's global assessment (PtGA) of the target joint between baseline and Day 90 or Day 180
Secondary Efficacy Endpoint
Measured: 90 Days, 180 Days
Proportion of subjects who report greater than the minimal clinically important difference (MCID) improvement in patient's global assessment (PtGA) compared to baseline at Day 90 or Day 180
Secondary Efficacy Endpoint
Measured: 90 Days, 180 Days
Number of OMERACT-OARSI "Strict Responders" at Day 90 or Day 180
Secondary Efficacy Endpoint
Measured: 90 Days, 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start24 Mar 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Why it stopped: Study discontinued early by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rho, Inc., United BioSource, LLC, NBCD A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796765
- Sponsor's protocol ID
- AIOA005
- Status last verified
- Jan 2024
- First submitted
- 21 Mar 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2B, Prospective, Double-Blind, Randomized Controlled Trial of the Micronized DHACM Injectable Product Compared to Saline Placebo Injection for the Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT05796765
- Acronym / sponsor ID
- AIOA005
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued early by Sponsor
- Enrolment
- 43 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rho, Inc., United BioSource, LLC, NBCD A/S
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of the 40 mg and 100 mg doses of allogeneic micronized dehydrated human amnion/chorion membrane (micronized DHACM) injectable compared to 0.9% sodium chloride injection, placebo control for the treatment of knee osteoarthritis
Detailed description
This is a phase 2B, prospective, double-blind, randomized controlled trial of the micronized DHACM injection as compared to saline placebo injection in the treatment of osteoarthritis of the knee. Approximately 30 experienced clinical centers in the United States and Denmark will participate in the study. Each subject will receive one injection and be evaluated for efficacy and safety during the 12-month observation period. Endpoints will be measured at 30 days, 60 days, 90 days, 120 days, 150 days, 180 days, 270 days and 365 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Micronized DHACM 40 mg | Experimental | Biological: Micronized DHACM 40 mgInjection of 40 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP |
| Micronized DHACM 100 mg | Experimental | Biological: Micronized DHACM 100 mgInjection of 100 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP |
| Saline | Placebo comparator | Drug: SalineInjection of 2.5 ml, 0.9% Sodium Chloride, USP |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Subject is age ≥ 21 and ≤ 80 years.
- Subject has a diagnosis of primary OA of the target knee (as per American College of Rheumatology clinical and radiological criteria) with OA symptoms (as reported by the subject) that have been present for at least 6 months prior to Screening.
- Subject has Grade 2 or 3 OA of the target knee on the Kellgren Lawrence (KL) grading scale as evaluated by central reading of screening X-ray.
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
- Subject must have a WOMAC pain score ≥ 4 and ≤ 9 out of 10 in target knee, at screening and baseline.
Key exclusion criteria (36 listed)
- Subject has Grade 1 or 4 OA of the target knee on the Kellgren Lawrence (KL) grading scale as evaluated by central reading of screening X-ray.
- Subject has a BMI greater than 40 kg/m^2.
- Subject has a clinical effusion (3+) of the target knee according to the Stroke Test grading system.
- Subject has symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an intra-articular loose body.
- Subject has any active infection of the target knee, and/or any active systemic or local infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronized DHACM 40 mgInjection of 40 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP | Biological | Micronized DHACM 40 mg |
| Micronized DHACM 100 mgInjection of 100 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP | Biological | Micronized DHACM 100 mg |
| SalineInjection of 2.5 ml, 0.9% Sodium Chloride, USP | Drug | Saline |
Primary outcome
Change in WOMAC pain subscale score between baseline and Day 180
Time frame: 180 days
Efficacy Endpoint
Change in WOMAC function subscale score between baseline and Day 180
Time frame: 180 days
Efficacy Endpoint
Proportions of subjects who report treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 365 days
Safety Endpoint
5 secondary outcomes
Proportion of subjects who report greater than the minimal clinically important difference (MCID) improvement in WOMAC pain and function compared to baseline at Day 90 or Day 180
Time frame: 90 Days, 180 Days
Change in SF-36 physical component score (PCS), mental component score (MCS), and domain scores between baseline and Day 90 or Day 180
Time frame: 90 Days, 180 Days
Change in patient's global assessment (PtGA) of the target joint between baseline and Day 90 or Day 180
Time frame: 90 Days, 180 Days
Proportion of subjects who report greater than the minimal clinically important difference (MCID) improvement in patient's global assessment (PtGA) compared to baseline at Day 90 or Day 180
Time frame: 90 Days, 180 Days
Number of OMERACT-OARSI "Strict Responders" at Day 90 or Day 180
Time frame: 90 Days, 180 Days
Results and safety
The study was stopped early (reason given: Study discontinued early by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micronized DHACM 40 mg, Micronized DHACM 100 mg and Saline in people with Knee Osteoarthritis, run by MiMedx Group, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study discontinued early by Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WOMAC pain subscale score between baseline and Day 180 (time frame: 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.